Please note, this OEL/ADE monograph also applies to diclofenac calcium (CAS RN 88170-10-9), diclofenac potassium (CAS RN 15307-81-0), diclofenac sodium (CAS RN 15307-79-6), diclofenac diethylamine (CAS RN 78213-16-8), diclofenac epolamine (CAS RN 119623-66-4), and diclofenac deanol (CAS RN 81811-14-5). Diclofenac is a non-steroidal anti-inflammatory agent (NSAID) indicated for the treatment of osteoarthritis, rheumatoid arthritis, dysmenorrhea, and other painful conditions. Diclofenac, a phenylacetic acid, is an NSAID that demonstrates analgesic, antipyretic, and anti-inflammatory activity. The anti-inflammatory effects of diclofenac are believed to be due to inhibition of both leukocyte migration and the enzyme cyclooxygenase (COX-1 and COX- 2), leading to the peripheral inhibition of prostaglandin synthesis. As prostaglandins sensitize pain receptors, inhibition of their synthesis is responsible for the analgesic effects of diclofenac. Antipyretic effects may be due to action on the hypothalamus, resulting in peripheral dilation, increased cutaneous blood flow, and subsequent heat dissipation.

Affygility Solutions has an occupational exposure limit (OEL) and control band assignment for this active pharmaceutical ingredient (API). This monograph also contains the acceptable daily exposure (ADE) value.


CAS Registry Number:
Diclofenac acid, Diclophenac
Brand names:
Cambia®, Cataflam®, Voltaren®, Voltaren- XR®, Zipsor®, and Voltarol® Emulgel®
$679 USD


Why do you need this OEL Fastrac monograph?

OEL Fastrac monographs are a cost-effective and convenient way to meet the requirements for PDEs (ADEs) contained in the EMA Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities (EMA/CHMP/CVMP/SWP/169430/2012), as well as PIC/S and ANVISA requirements, and to obtain the following information:

  • The numerical OEL and control band assignment needed to determine the level of required engineering controls and personal protective equipment
  • A listing of all cited references utilized in the derivation of the OEL and ADE
  • An expert review and discussion with respect to the critical endpoints of concern, the rationale for the choice of endpoints, and dose that is to be used in the derivation of the ADE (PDE), as required by the EMA's Guideline on setting health-based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities

Benefits of OEL Fastrac monographs

  • Fully documented. Over 20 pages in length, with calculations and cited references.
  • Save time! Unsurpassed delivery with instant download.
  • Save money. Similar documents cost 5-12 times as much.
  • Stay current. Automatic notification of revisions.

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  • K. Rosenthal
  • Director of Manufacturing